Evaluation of Serum Ceramides C16, C24, and Sphingosine-1-Phosphate (S1P) in Patients With Acne Vulgaris (CER-S1P-ACNE)

November 18, 2025 updated by: Dalia Ahmed Helmy Ahmed, Sohag University

Acne vulgaris is a common chronic inflammatory skin disorder that affects adolescents and young adults. Recent research has shown that lipid mediators, including ceramides and sphingolipids, play an important role in maintaining skin barrier function and inflammation.

This study aims to evaluate the serum levels of ceramide C16, ceramide C24, and sphingosine-1-phosphate (S1P) in patients with acne vulgaris and compare them to healthy controls. The goal is to explore their possible role in the pathogenesis and severity of acne. Blood samples will be collected from participants, and quantitative analysis will be performed using liquid chromatography-tandem mass spectrometry (LC-MS/MS).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Acne vulgaris involves complex biochemical and immunologic mechanisms that extend beyond the traditional concepts of follicular obstruction and increased sebum production. Emerging evidence highlights the contribution of systemic lipid mediators-particularly sphingolipids-in influencing keratinocyte behavior, sebaceous gland activity, and inflammatory signaling pathways. Disturbances in circulating ceramides and their downstream metabolites may reflect dysregulated lipid homeostasis that parallels the clinical manifestations of acne.

In this study, specific attention is given to three sphingolipid biomarkers that have been increasingly linked to cutaneous biology: Ceramide C16, Ceramide C24, and Sphingosine-1-phosphate (S1P). These molecules participate in cell differentiation, apoptosis, and immune responses, and their altered levels may provide insight into acne-related metabolic shifts. By quantitatively assessing their serum concentrations in affected individuals and comparing them with healthy subjects, the study aims to characterize potential biochemical patterns associated with disease presence and activity.

All biological samples will be processed using a validated LC-MS/MS analytical platform to ensure precise measurement of each sphingolipid species. The findings may help to clarify whether systemic sphingolipid disturbances contribute to acne pathophysiology and could support the development of lipid-based biomarkers or therapeutic strategies in future dermatologic research.

Study Type

Observational

Enrollment (Estimated)

80

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Study Population:

A. Inclusion Criteria:

For Case Group

This group will consist of (40) patients :

  • Both males and females aged 15-40 years.
  • Mild, Moderate, severe and very severe cases will be included. 5

For Control Group:

• This group will consist of age- and sex-matched (40) healthy volunteers.

B. Exclusion Criteria (for both groups):

  • Presence of any dermatological condition other than acne vulgaris (for cases).
  • Use of systemic or topical treatment such as isotretinoin or antibiotics within the last 3 months.
  • Pregnancy or lactation.
  • History of lipid-lowering therapy or supplements affecting ceramide or sphingolipid metabolism

Description

Inclusion Criteria:

  • For Case Group

This group will consist of (40) patients :

  • Both males and females aged 15-40 years.
  • Mild, Moderate, severe and very severe cases will be included. 5

For Control Group:

• This group will consist of age- and sex-matched (40) healthy volunteers.

Exclusion Criteria:

  • Presence of any dermatological condition other than acne vulgaris (for cases).

    • Use of systemic or topical treatment such as isotretinoin or antibiotics within the last 3 months.
    • Pregnancy or lactation.
    • History of lipid-lowering therapy or supplements affecting ceramide or sphingolipid metabolism.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Acne vulgaris patients

Both males and females aged 15-40 years.

• Mild, Moderate, severe and very severe cases will be included
Other: Blood sample collection for biochemical analysis of serum ceramides (C16, C24) and sphingosine-1-phosphate (S1P).
Venous blood samples (5 mL) will be collected from all participants under aseptic conditions. Serum will be separated and stored at -80°C until analysis. Quantitative estimation of ceramide C16, ceramide C24, and sphingosine-1-phosphate (S1P) will be performed using liquid chromatography-tandem mass spectrometry (LC-MS/MS). No therapeutic intervention will be given.
Healthy controls

Healthy controls

Description:

Age- and sex-matched healthy volunteers
Other: Blood sample collection for biochemical analysis of serum ceramides (C16, C24) and sphingosine-1-phosphate (S1P).
Venous blood samples (5 mL) will be collected from all participants under aseptic conditions. Serum will be separated and stored at -80°C until analysis. Quantitative estimation of ceramide C16, ceramide C24, and sphingosine-1-phosphate (S1P) will be performed using liquid chromatography-tandem mass spectrometry (LC-MS/MS). No therapeutic intervention will be given.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum levels of Ceramide C16, Ceramide C24, and Sphingosine-1-Phosphate (S1P)
Time Frame: At baseline (single visit)
Quantitative assessment of serum concentrations of Ceramide C16, Ceramide C24, and Sphingosine-1-Phosphate (S1P) in acne vulgaris patients and healthy controls using liquid chromatography-tandem mass spectrometry (LC-MS/MS).
At baseline (single visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 18, 2025

First Posted (Actual)

November 26, 2025

Study Record Updates

Last Update Posted (Actual)

November 26, 2025

Last Update Submitted That Met QC Criteria

November 18, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-25-10-11MS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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